MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIGGER HANDLE F/CABLE CUTTER; CUTTER,WIRE

Model Number 03.221.006

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on an unknown date, two (2) cable cutters was observed dull, won't cut cables.The cable cutter with trigger handle was also noticed to have a broken part and doesn't work, while the blade for cable cutter doesn't cut properly.A wire cutter with an unknown allegation was also reported.It is unknown how the issue was discovered.It is unknown if there were patient and surgical involvement.This complaint involves five (5) devices.This report is for (1) cable cutter w/trigger handle.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part 03.221.007, lot t106490: manufacturing site: tuttlingen.Release to warehouse date: february 19, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.H3, h6: an updated product investigation was completed: upon visual inspection, it was observed that the components (pusher and m4 shoulder bolt) were missing.The trigger component is loose and moving free which impacts the functionality of the device.There were few nicked spots found on the handle component.But no broken features were noticed with the returned device.Functional test of the received device cannot be performed due to the missing components.The relevant drawings were reviewed during the investigation; no design issues or discrepancies were noted during the investigation.The complaint is being confirmed as the received device missing components and trigger is loose.But the reported broken condition cannot be confirmed.While a definitive root cause could not be determined, it is possible that the components might have got misplaced during sterilization.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 03.221.006, lot: t106490, manufacturing site: tuttlingen, release to warehouse date: february 19, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Visual inspection: trigger handle f/cable cutter was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the components (pusher and m4 shoulder bolt) were missing.The trigger component is loose and moving free which impacts the functionality of the device.There were few nicked spots found on the handle component.But no broken features were noticed with the returned device.Functional test: functional test of the received device cannot be performed at cq due to the missing components.Dimensional inspection: dimensional inspection of the received device was not performed at cq as it is evident that the device is missing components.Document/ specification review: the following drawings were reviewed during the investigation: -cable cutter, handle with trigger -m4 shoulder bolt -pusher no design issues or discrepancies were noted during the investigation.Investigation conclusion: the complaint is being confirmed for trigger handle f/cable cutter as the received device missing components and trigger is loose.But the reported broken condition cannot be confirmed.While a definitive root cause could not be determined, it is possible that the components might have got misplaced during sterilization.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRIGGER HANDLE F/CABLE CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10920627
• MDR Text Key: 218918490
• Report Number: 2939274-2020-05358
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076694
• UDI-Public: (01)10886982076694
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.221.006
• Device Catalogue Number: 03.221.007
• Device Lot Number: T106490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/28/2020
• Patient Sequence Number: 1
• Treatment: BLADE FOR CABLE CUTTER; CABLE CUTTER-LARGE; CABLE CUTTER-LARGE; WIRE CUTTER 220MM